(B13) Evaluation Suboptimal Outcomes in Crohn's Disease Patients with Biologic Treatment

Saturday, August 26, 2023

8:00 AM – 6:00 PM ADT

Location: Convention Hall C5

Publication Number: 625

Presenting Author(s)

Nai-Yu Chen, PhD candidate

Pharmacist
School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Tainan, Taiwan (Republic of China)

Background: Biological agent is crucial for moderate to severe Crohn's disease (CD). Apply conventional observational study designs to evaluating biologicals for autoimmune disease is difficult to identify suitable comparison groups. We also lacked of information about the effectiveness within biologic treatment period in real-world evidence.

Objectives: To investigate the association between adalimumab use and risk of suboptimal outcomes in CD patients.

Methods: This self-controlled case series study analyzed Taiwan’s National Health Insurance Database from 2010 to 2018 to identify CD patients (ICD-9/10-CM codes [555.x/K50.x]), aged ≥ 20 years, receiving catastrophic illness certificate and adalimumab treatment. Study period defined from 6 months before the first adalimumab prescription date to 218/12/31. We defined different risk period as: pre- adalimumab, during-adalimumab, and post-adalimumab compared with the non- adalimumab period in the same individual. The composite suboptimal outcomes, including CD related hospitalization, emergency room visit and surgery. We performed conditional Poisson regressions to generate incidence rate ratios (IRR) and 95% confidence intervals (CI).

Results: Of 506 CD patients with adalimumab treatment were identified between 2011 and 2018. We enrolled 306 incident cases (60%) of suboptimal outcomes, mean (SD) age 38.6 (15.3), 68.6% male, 82% endoscope experience, high proportion with conventional medication including 5-aminosalicylic acid, immunomodulators or corticosteroid 1-year before index date. Compared with non- adalimumab, the risk of suboptimal outcomes was lower in during-adalimumab period (IRR: 0.48, 95% CI: 0.39–0.58). Then we found a higher risk of suboptimal outcomes in pre- adalimumab period (IRR=2.85, 95% CI: 2.21–3.69 for pre 31-60 days and IRR=2.49, 95% CI: 1.91–3.26 for pre 1-30 days), followed by post-adalimumab period (post 1-30 days IRR=1.62, 95% CI: 1.14–2.28, and post 31-60 days IRR=1.91, 95% CI: 1.38–2.65).

Conclusions: CD patients treated with adalimumab significant decreased risk of suboptimal outcomes. Within 2 months after adalimumab or biologic discontinuation a close monitoring of suboptimal outcomes is suggestion to evaluate re-use of biologics in CD patients.